Join a global medical device company as a Regulatory Affairs Manager responsible for leading regulatory strategy and product submissions in Japan. In this high-impact role, you will work closely with PMDA and MHLW, ensuring new medical technologies meet Japanese regulatory requirements for successful market introduction. Your expertise will directly support product approvals, risk reduction, and compliance across the organization.
Key Responsibilities
- Develop and execute regulatory submission strategies for product approvals in Japan.
- Communicate complex regulatory information clearly and effectively across teams.
- Lead cross-functional projects involving government agencies (PMDA/MHLW) and external stakeholders.
- Interpret expectations from health authorities and navigate discussions to drive successful outcomes.
- Apply deep understanding of Japan's medical device laws to support compliance and reduce regulatory risks.
Required Skills and Qualifications
Experience:
- Bachelor's degree or higher.
- 3+ years of regulatory affairs experience in the medical device industry.
- Experience preparing regulatory submissions and managing communication with authorities.
Soft Skills:
- Excellent verbal and written communication, with strong influencing and team-building abilities.
- Strong listening skills, analytical thinking, and the ability to ask insightful questions.
- High motivation, discipline, and strong problem-solving skills.
Language Requirements:
- Japanese: Native level.
- English: Intermediate to business level for meetings, documentation, and global coordination.
Preferred Skills & Qualifications
About the Company
Our client is a global medical device organization specializing in regulatory submissions and market access for advanced healthcare technologies in Japan. They partner closely with government agencies to ensure medical devices meet all safety and regulatory standards, enabling hospitals and clinicians to access innovative solutions that improve patient care.
Why You'll Love Working Here
- Lead strategic regulatory initiatives for new medical product approvals.
- Engage directly with PMDA and MHLW to influence regulatory outcomes.
- Strengthen internal compliance systems using expert knowledge of Japanese device laws.
Don't Miss Out - Apply Now!
